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Dilaudid
hydromorphone
Black Box Warnings .
Appropriate Use
should only be prescribed by healthcare professionals knowledgeable about opioid use and how to mitigate associated risks; reserve opioid analgesics for patients with inadequate tx alternatives; ER form not indicated for prn analgesic use; proper dosing and titration essential to decr. respiratory depression risk
Medication Error Risk
ensure accuracy when prescribing, dispensing, and administering hydromorphone oral solution; dosing errors due to confusion between mg and mL or different concentrations can result in accidental overdose and death; hydromorphone injection high potency formulation (10 mg per mL) for use in opioid-tolerant patients only; do not confuse with standard parenteral hydromorphone forms, overdose and death could result
Addiction, Abuse, and Misuse
opioid agonist Schedule II controlled substance with risk of addiction, abuse, and misuse, which can lead to overdose and death; assess opioid abuse or addiction risk prior to prescribing; regularly reassess all patients for misuse, abuse, and addiction
Respiratory Depression
serious, life-threatening, or fatal cases may occur even with recommended use, especially during tx start or after dose incr; to decr. risk, initiate and titrate dose appropriately; instruct patients to swallow ER tabs whole to avoid exposure to potentially fatal hydromorphone dose
Accidental Ingestion
accidental ingestion of even one dose, especially by children, can result in fatal hydromorphone overdose
Risks from Concomitant Use with Benzodiazepines, CNS Depressants
concomitant opioid use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death; reserve concomitant use for patients with inadequate alternative tx options
Neonatal Opioid Withdrawal Syndrome
advise pregnant patients with extended opioid use of risk of potentially life-threatening neonatal opioid withdrawal syndrome; ensure tx by neonatology experts available at delivery
Opioid Analgesic REMS
providers are strongly encouraged to complete risk evaluation and mitigation strategy (REMS)-compliant education program, counsel patients and/or caregivers with each Rx on serious risks, safe use, and importance of reading medication guide
Adult Dosing .
Dosage forms: TAB: 2 mg, 4 mg, 8 mg; SOLUTION: 1 mg per mL; INJ (pre-filled syringe): 0.5 mg per 0.5 mL, 1 mg per mL, 2 mg per mL, 4 mg per mL
Dosage Form Details
- [SUPPOSITORY form discontinued in US for this brand; see generic]
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, moderate-severe
- [PO route, tablet]
- Dose: individualize dose PO q3-6h prn; Start: 2-4 mg PO q4-6h prn; Info: in patients converting from other opioids, consider starting 1-2 mg PO q4-6h prn; use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PO route, oral solution]
- Dose: individualize dose PO q3-6h prn; Start: 2.5-10 mg PO q3-6h prn; Info: in patients converting from other opioids, consider starting 1.25-5 mg PO q3-6h prn; use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [parenteral route]
- Dose: individualize dose IV/SC/IM q2-3h prn; Start: 0.2-1 mg IV q2-3h prn; 1-2 mg SC/IM q2-3h prn; Info: IV preferred to SC/IM; use lowest effective dose, shortest effective tx duration; consider low start dose, titrate slowly in patients 65 yo and older; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [rectal route]
- Dose: 3 mg PR q6-8h prn; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PCA route (off-label)]
- Dose: 0.05-0.4 mg IV q6-20min prn; Start: 0.1-0.5 mg IV x1; Info: basal rate for opioid-experienced patients is up to 0.5 mg/h; dosing varies, refer to institution protocol; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [PO route]
- CrCl <80: decr. usual start dose by 50-75%
- HD: start 0.5-1 mg q6h prn; no supplement after dialysis; PD: start 0.5-1 mg q6h prn; no supplement
- [parenteral route]
- CrCl <80: decr. usual start dose by 50-75%
- HD: decr. usual start dose, amount not defined; no supplement after dialysis; PD: decr. usual start dose, amount not defined; no supplement
- [rectal route]
- renal impairment: not defined, caution advised
- HD/PD: not defined, caution advised
hepatic dosing
- [PO route]
- Child-Pugh Class B: decr. usual start dose by 50-75%; Child-Pugh Class C: decr. usual start dose, amount not defined, titrate slowly
- [parenteral route]
- Child-Pugh Class B: decr. usual start dose by 50-75%; Child-Pugh Class C: decr. usual start dose, amount not defined, titrate slowly
- [rectal route]
- hepatic impairment: not defined, caution advised
Peds Dosing .
- Dosage forms: TAB: 2 mg, 4 mg, 8 mg; SOLUTION: 1 mg per mL; INJ (pre-filled syringe): 0.5 mg per 0.5 mL, 1 mg per mL, 2 mg per mL, 4 mg per mL
Special Note
- [prescribing info]
- Info: consider prescribing opioid overdose reversal agent (e.g., naloxone, nalmefene), especially if risk of opioid overdose or accidental ingestion
pain, moderate-severe (off-label)
- [PO route, 6 mo and older, <50 kg]
- Dose: individualize dose PO q3-4h prn; Start: 30-80 mcg/kg/dose PO q3-4h prn; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PO route, 6 mo and older, >50 kg]
- Dose: individualize dose PO q3-4h prn; Start: 1-2 mg PO q3-4h prn; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [parenteral route, 6 mo and older, <50 kg]
- Dose: individualize dose IV q2-6h prn; Start: 15-20 mcg/kg/dose IV q2-6h prn; Alt: 6 mcg/kg/h IV; Info: use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [parenteral route, 6 mo and older, >50 kg]
- Dose: individualize dose IV/SC/IM q2-6h prn; Start: 0.2-0.6 mg IV q2-4h prn; 0.8-1 mg SC/IM q4-6h prn; Alt: 0.3 mg/h IV; Info: IV preferred to SC/IM; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PCA route, <50 kg]
- Dose: 2-5 mcg/kg/dose IV q6-20min prn; Start: 8 mcg/kg/dose IV x1; Max: 20 mcg/kg/h; Info: basal rate for opioid-experienced patients is up to 3 mcg/kg/h; dosing varies, refer to institution protocol; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
- [PCA route, >50 kg]
- Dose: 0.05-0.4 mg IV q6-20min prn; Start: 0.1-0.5 mg IV x1; Info: basal rate for opioid-experienced patients is up to 0.5 mg/h; dosing varies, refer to institution protocol; use lowest effective dose, shortest effective tx duration; taper dose gradually to avoid withdrawal symptoms if D/C tx in physically opioid-dependent patients; search 'opioid taper' for epocrates Opioid Tapering decision tool
renal dosing
- [see below]
- renal impairment: decr. usual dose, amount not defined
- HD/PD: not defined, caution advised
hepatic dosing
- [not defined]
- hepatic impairment: consider adult hepatic dosing for guidance